FDA Requests More Information Before Approving Lung Drug for Infants
Drug manufacturer AstraZeneca PLC will reportedly have to provide the Food and Drug (FDA) Administration with more information about their new lung drug for infants before the agency will grant permission for it to be released onto the market. As reported by the Associated Press (AP), the company announced on Friday that the FDA requested more information about Motavizumab, which was developed for the prevention of lung infections in babies.
AstraZeneca spokesperson Sarah Lindgreen was quoted as stating “We’re not yet speculating on what impact it will have on a possible launch date.” However, there is a possibility that the company will not be able to meet their original release date goal in 2009 due to complying with the request.
As noted in the report, AstraZeneca currently has another respiratory virus treatment on the market, Synergis, which analysts list as one reason the possible delay may not significantly impact the company’s sales.
Tags: AstraZeneca, Drug, FDA, lung, manufacturer, Motavizumab, SynergisOnline Health & Fitness News Press Release Distribution - WiredPRNews.com
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